Spectranetics Receives CE Mark For TightRail(TM) Rotating Dilator Sheath Platform

COLORADO SPRINGS, Colo., May 22, 2014 (GLOBE NEWSWIRE) -- The Spectranetics Corporation (Nasdaq:SPNC) today announced receipt of CE marking for the TightRail™ Rotating Dilator Sheath platform. The product combines unprecedented shaft flexibility and column strength to help physicians safely navigate the vasculature during cardiac lead extraction procedures. The announcement includes TightRail and a companion product: TightRail™ Mini Rotating Dilator Sheath. The Mini is designed to gain vascular access, dilating heavily fibrosed and calcified tissue. The new platform will be used to treat patients at facilities in Europe that are participating in Spectranetics' initial limited launch.
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SightRail™ Manual Dilator Sheath, a partner platform, was awarded the CE mark in April and features visual indicators that show bevel orientation and tip alignment, supplementing fluoroscopy as a means to determine position and orientation These new platforms represent Spectranetics' entry into the mechanical extraction device market, complementing the laser-based technology that established the company's leading position in cardiac lead extraction.

On the heels of completing TightRail's first in-patient case with Dr. Charles Love, Spectranetics debuted TightRail at the Heart Rhythm Society's 35th Annual Scientific Sessions in San Francisco earlier this month. Over 200 physicians participated in the "hands-on" Solutions Experience hosted by Spectranetics. TightRail will also headline the CardioStim conference in Nice, France, in June. Donna Ford-Serbu, Senior Vice President, Sales and Marketing for Spectranetics Lead Management business unit, sees the mechanical extraction devices as an exciting addition to the company's portfolio of lead extraction solutions. "By providing a wider range of clinical solutions, we are responding to a global need for innovative extraction options," said Ford-Serbu. "Physicians are always looking for ways to serve their patient's needs – we are committed to providing tools that extend life and ensure physicians are successful at every turn." There are over seven million implanted cardiac devices globally. Each year, about 750,000 additional patients are implanted with these devices worldwide, translating to 1.5 million leads. It is estimated that in 2014, roughly 400,000 patients will meet indications for a lead extraction procedure.

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